[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100212425":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":31,"locations":40,"responsibleParty":189,"collaborators":35,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":35,"enrollmentInfo":200,"targetDuration":35,"studyType":203,"phases":204,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":54,"whyStopped":35,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus treatment","EXPERIMENTAL","Patients will receive sirolimus (Rapamune). The dose should be adjusted to obtain a residual plasma rate of 8 to 12 ng\u002Fml in 4 weeks. This serum level will be maintained throughout the duration of the study in the absence of side effects. In case of intolerance that do not justify the discontinuation of treatment, the dose may be reduced by maintaining a serum level greater than 3 ng\u002Fml.\n\nThe starting dose will be 2 mg per day, and will be adapted every week for one month.\n\nThe preferred dosage form is tablet form. To prevent common side effects in early treatment, corticosteroids based prednisolone (SOLUPRED) will be established at a dose of 0.5 mg\u002F kg\u002Fday for the first week of treatment.",[13],"Drug: Sirolimus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sirolimus","For patients with swallowing problems, and for children under 6 years and \u002F or who have an inability to swallow tablets, the 1mg\u002Fml solution form should be used.",[9],[21],"Rapamune",[23,27],{"name":24,"affiliation":25,"role":26},"Bernard DEVAUCHELLE, MD, PhD","CHU Amiens","STUDY_DIRECTOR",{"name":28,"affiliation":29,"role":30},"Emmanuel MORELON, MD, PhD","HCL Lyon","STUDY_CHAIR",[32,37],{"name":24,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+33322668325",null,"devauchelle.bernard@chu-amiens.fr",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Sylvie TESTELIN, MD, PhD","testelin.sylvie@chu-amiens.fr",[41,53,69,78,91,100,119,135,144,153,162,171,180],{"facility":42,"status":43,"city":44,"state":35,"zip":35,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":35},"UCL","NOT_YET_RECRUITING","Brussels","Belgium","BE",{"type":48,"coordinates":49},"Point",[50,51],4.34878,50.85045,{"lat":51,"lon":50},{"facility":25,"status":54,"city":55,"state":35,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"RECRUITING","Amiens","80000","France","FR",{"type":48,"coordinates":60},[61,62],2.3,49.9,{"lat":62,"lon":61},[65,67],{"name":24,"role":66,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"name":38,"role":68,"phone":35,"phoneExt":35,"email":35},"SUB_INVESTIGATOR",{"facility":70,"status":43,"city":71,"state":35,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":35},"CHU 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Lille","Lille","59000",{"type":48,"coordinates":96},[97,98],3.05512,50.63391,{"lat":98,"lon":97},{"facility":29,"status":54,"city":101,"state":35,"zip":102,"country":57,"countryCode":58,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Lyon","69000",{"type":48,"coordinates":104},[105,106],4.84789,45.74906,{"lat":106,"lon":105},[109,112,115,117],{"name":110,"role":33,"phone":35,"phoneExt":35,"email":111},"Pierre BRETON, MD PhD","pierre.breton@chu-lyon.fr",{"name":113,"role":33,"phone":35,"phoneExt":35,"email":114},"Laurent GUIBAUD, MD PhD","laurent.guibaud@chu-lyon.fr",{"name":116,"role":66,"phone":35,"phoneExt":35,"email":35},"Pierre BRETON",{"name":118,"role":66,"phone":35,"phoneExt":35,"email":35},"Laurent GUIBAUD",{"facility":120,"status":43,"city":121,"state":35,"zip":122,"country":57,"countryCode":58,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"APHM","Marseille","13000",{"type":48,"coordinates":124},[125,126],5.38107,43.29695,{"lat":126,"lon":125},[129,132,134],{"name":130,"role":33,"phone":35,"phoneExt":35,"email":131},"Stéphanie MALLET, MD","stephanie.mallet@ap-hm.fr",{"name":133,"role":66,"phone":35,"phoneExt":35,"email":35},"Jean-Michel BARTOLI",{"name":130,"role":68,"phone":35,"phoneExt":35,"email":35},{"facility":136,"status":43,"city":137,"state":35,"zip":138,"country":57,"countryCode":58,"cosmosGeoPoint":139,"geoPoint":143,"contacts":35},"CHU Montpellier","Montpellier","34000",{"type":48,"coordinates":140},[141,142],3.87635,43.61093,{"lat":142,"lon":141},{"facility":145,"status":43,"city":146,"state":35,"zip":147,"country":57,"countryCode":58,"cosmosGeoPoint":148,"geoPoint":152,"contacts":35},"CHU Nancy","Nancy","54000",{"type":48,"coordinates":149},[150,151],6.18496,48.68439,{"lat":151,"lon":150},{"facility":154,"status":43,"city":155,"state":35,"zip":156,"country":57,"countryCode":58,"cosmosGeoPoint":157,"geoPoint":161,"contacts":35},"CHU Nice","Nice","06000",{"type":48,"coordinates":158},[159,160],7.26608,43.70313,{"lat":160,"lon":159},{"facility":163,"status":43,"city":164,"state":35,"zip":165,"country":57,"countryCode":58,"cosmosGeoPoint":166,"geoPoint":170,"contacts":35},"APHP","Paris","75000",{"type":48,"coordinates":167},[168,169],2.3488,48.85341,{"lat":169,"lon":168},{"facility":172,"status":43,"city":173,"state":35,"zip":174,"country":57,"countryCode":58,"cosmosGeoPoint":175,"geoPoint":179,"contacts":35},"CHU Strasbourg","Strasbourg","67000",{"type":48,"coordinates":176},[177,178],7.74553,48.58392,{"lat":178,"lon":177},{"facility":181,"status":43,"city":182,"state":35,"zip":183,"country":57,"countryCode":58,"cosmosGeoPoint":184,"geoPoint":188,"contacts":35},"CHU Tours","Tours","37000",{"type":48,"coordinates":185},[186,187],0.70398,47.39484,{"lat":187,"lon":186},{"type":190,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100212425","phase-2-prospective-evaluation-of-the-efficacy-of-sirolimus-rapamune-in-the-treatment-of-severe-arteriovenous-malformations-100212425",false,"NCT02042326","Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations","MAV-RAPA","Inclusion Criteria:\n\n* Patients (adults, adolescents and children older than 2 years), with arteriovenous malformation stage II + III or IV (according to Schöbinger's classification) : active or quiescent, marked or not by hemorrhagic phenomena.\n* Patients (parents for minors) must sign a consent form established after clear information risks and expected benefits of the study.\n* Patients (major and minor of childbearing age) must have effective contraception during the study period and continuing until 12 weeks after the end of treatment\n* Negative pregnancy blood test for women of childbearing age.\n\nExclusion Criteria:\n\n* Chronic or acquired immunosuppression :\n\n  * patients with transplanted organ or who received a hematopoietic stem cell\n  * patient with congenital immunodeficiency\n* Patients implanted with chronic active infection associated with hepatitis B , hepatitis C or HIV\n* Pregnant or nursing woman.\n* Allergy to macrolides\n* Allergy to peanut or soya\n* Hypersensitivity to \" Sirolimus \" or any of the excipients of the investigational product\n* Contraindications to performing an MRI\n* Leukopenia below 1 000 \u002Fmm3\n* Thrombocytopenia lower to 80,000 \u002Fmm3\n* Anemia with Hb \\\u003C 9 g\u002Fdl\n* Elevated transaminase \\> 2.5 N\n* History of cancer less than two years before the inclusion\n* Surgery older than 2 months before inclusion\n* Active infection (viral and bacterial ) on the date of inclusion\n* Hypercholesterolemia \\> 7 mmol \u002F l despite appropriate medical treatment\n* Hyperlipidemia \\> 2 mmol \u002F l despite appropriate medical treatment\n* Uncontrolled diabetes\n* Patients unable to follow a clinical study\n* Major under guardianship, persons deprived of their liberty","ALL","2 Years",{"count":201,"type":202},50,"ESTIMATED","INTERVENTIONAL",[205],"PHASE2","The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).\n\nSirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.",[208],"Arteriovenous Malformations",[208,17,210],"Maxillofacial Surgery","2026-05-12",{"date":213,"type":214},"2026-05-13","ACTUAL",{"date":216,"type":214},"2014-09-12",{"date":218,"type":202},"2027-09",{"name":5,"class":6},13]